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ISO 13485:2003

Argos Translations is only one of a handful of translation service companies possessing the ISO 13485 certification specific to medical device quality assurance processes.

The medical device standard ISO 13485 is a member of the ISO standards family and “specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services”. Medical companies expect this certification from their vendors and Argos is equipped to meet their requirements.

Being a company that doesn’t produce medical devices, only a portion of this standard applies to Argos - mainly related to quality assurance processes, quality management system and including a risk management system.

Since the medical device standard is a standard not directly applicable to the translation industry, only highly specialized and quality oriented translation companies can meet its strict registration and conformity norms. Having an advanced Quality Management System and a focused approach to quality, Argos was able to adjust its workflows to conform and meet the requirements of ISO 13485 certification.

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